RxSight Light Adjustable Lens (RxLAL) 60005-3050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020906), received between Jul 14, 2023 and Jun 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +5.0D) WAS EXPLANTED, AND A TORIC LENS (+5.0D SPHERE, 6.00D CYLINDER) FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/15/2024.

  Patient problems: Visual Impairment

  MAUDE report 19534403 ↗
• InjuryJul 14, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +5.0D) WAS EXPLANTED ON (B)(6)2023 AND WAS REPLACED WITH A +11.0D LAL (SN (B)(6)). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 17330298 ↗